WO2019186230A1 - Pressure regulator for verifying the inflation of balloons of endotracheal cannulas or tubes - Google Patents

Pressure regulator for verifying the inflation of balloons of endotracheal cannulas or tubes Download PDF

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Publication number
WO2019186230A1
WO2019186230A1 PCT/IB2018/052059 IB2018052059W WO2019186230A1 WO 2019186230 A1 WO2019186230 A1 WO 2019186230A1 IB 2018052059 W IB2018052059 W IB 2018052059W WO 2019186230 A1 WO2019186230 A1 WO 2019186230A1
Authority
WO
WIPO (PCT)
Prior art keywords
pressure
pressure regulator
regulator according
chamber
balloon
Prior art date
Application number
PCT/IB2018/052059
Other languages
Spanish (es)
French (fr)
Inventor
Héctor de Jesús VELEZ RIVERA
Original Assignee
Velez Rivera Hector De Jesus
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Velez Rivera Hector De Jesus filed Critical Velez Rivera Hector De Jesus
Priority to PCT/IB2018/052059 priority Critical patent/WO2019186230A1/en
Priority to US17/040,847 priority patent/US20220105321A1/en
Priority to MX2020009932A priority patent/MX2020009932A/en
Publication of WO2019186230A1 publication Critical patent/WO2019186230A1/en
Priority to CONC2020/0013109A priority patent/CO2020013109A2/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1018—Balloon inflating or inflation-control devices
    • A61M25/10184—Means for controlling or monitoring inflation or deflation
    • A61M25/10187—Indicators for the level of inflation or deflation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0402—Special features for tracheal tubes not otherwise provided for
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0434—Cuffs
    • A61M16/044—External cuff pressure control or supply, e.g. synchronisation with respiration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/20—Valves specially adapted to medical respiratory devices
    • A61M16/208—Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves
    • G—PHYSICS
    • G05—CONTROLLING; REGULATING
    • G05D—SYSTEMS FOR CONTROLLING OR REGULATING NON-ELECTRIC VARIABLES
    • G05D16/00—Control of fluid pressure
    • G05D16/04—Control of fluid pressure without auxiliary power
    • G05D16/10—Control of fluid pressure without auxiliary power the sensing element being a piston or plunger
    • G05D16/103—Control of fluid pressure without auxiliary power the sensing element being a piston or plunger the sensing element placed between the inlet and outlet
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
    • A61M2016/0027—Accessories therefor, e.g. sensors, vibrators, negative pressure pressure meter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2206/00—Characteristics of a physical parameter; associated device therefor
    • A61M2206/10—Flow characteristics
    • A61M2206/14—Static flow deviators in tubes disturbing laminar flow in tubes, e.g. archimedes screws

Definitions

  • the present invention is related to the techniques employed in the design and construction of apparatus and devices for medical use and, more particularly, it is related to a pressure regulator for cannula balloons or endotracheal tubes which, automatically prevents having a pressure greater than a pressure established in the balloon for the correct intubation of a patient.
  • Endotracheal cannulas or tubes are commonly used in airway management, particularly during general anesthesia, critical care, mechanical ventilation and / or emergency medicine.
  • a connector that is an intermediate piece between the cannula or the tube and some respirator or gas source directed at the patient;
  • the connector is usually a standard mechanical part with a Luer type connection well known to those skilled in the art.
  • the main part of the cannulas or tubes is itself the elongated body, duct or tube that carries the flow of gas from the source that supplies the gases to the patient.
  • the tube normally has a circular cross section.
  • an inflatable part known as a balloon, balloon or pneumo which, when inflated, puts pressure on the tracheal mucosa for the correct positioning of the cannula or tube inside the patient.
  • the pressure inside the balloon must be maintained at certain values such as 25 cm of H 2 0.
  • manually operated valves are used, in this particular, it is important to mention that the pressure in the balloon it must be maintained at optimal values to avoid damage to the patient.
  • a pressure regulator has been developed to verify the inflation of balloons of the cannulas or endotracheal tubes
  • the regulator comprises as main elements: a housing that includes an inlet to feed a gaseous fluid and an outlet where a cannula or endotracheal tube connector is attached that includes a balloon around a portion of its distal end.
  • the housing is divided into a flow chamber and a pressure regulation chamber.
  • a unidirectional valve mounted at the inlet to allow only the entry of the gaseous fluid into the flow chamber and avoid leaks or the return of the gaseous fluid that decreases the required pressure in the balloon.
  • a plurality of baffles mounted in the flow chamber is provided to reduce the velocity of the gaseous fluid within said chamber, in this sense, the plurality of baffles defines a flow path between the inlet and the outlet, where the latter is in flow communication with both the flow chamber and the pressure regulating chamber.
  • the plurality of baffles comprises vertical baffles and horizontal baffles such that a horizontal baffle is followed by a vertical baffle. It is even more preferred that the horizontally positioned baffles partially cover the cross section of the flow chamber.
  • the flow chamber has a front wall and a rear wall, so that each of the horizontal baffles is internally separated from both the front wall and the back wall so that the gaseous fluid flows through the separation between the deflector and said front or rear wall.
  • a pressure indicating piston is mounted movably mounted in the pressure regulating chamber and is visible by the user, likewise, a sealing piston is operatively connected with the indicating piston and below it in such a way that both can move simultaneously.
  • a wall is provided to separate the flow chamber from the pressure regulating chamber.
  • the pressure regulating chamber has a preferably transparent upper wall where the indicating piston is visible in case it moves upwards when the preset pressure value in the balloon exceeds, from another point of view, the transparent wall allows to know if the balloon is inflated to the correct pressure.
  • at least one relief orifice is provided located in the pressure regulating chamber, said orifice communicates the interior of the housing with the environmental exterior, and said orifice is located blocked by the sealing piston when the pressure in the balloon is less than the preset value.
  • the regulating chamber has a front wall and a rear wall, each wall including at least one relief hole. More particularly, it is preferred to provide a group of three holes both in the front wall and another group in the rear wall, where the holes in each group are distributed horizontally and equidistant from each other.
  • the present invention also includes tension means comprising a base or anchor mounted to the housing and a flexible element that connects the base with the sealing piston such that the flexible element is tense to keep the sealing piston in a locked position when the pressure in the balloon is lower than said predetermined value and in case there is a higher pressure in the balloon, the tension in the flexible element is overcome to move the sealing piston upwards and thereby move the indicating piston upwards releasing said at least one relief hole through which the gaseous fluid can escape and thus return to the required pressure in the balloon.
  • tension means comprising a base or anchor mounted to the housing and a flexible element that connects the base with the sealing piston such that the flexible element is tense to keep the sealing piston in a locked position when the pressure in the balloon is lower than said predetermined value and in case there is a higher pressure in the balloon, the tension in the flexible element is overcome to move the sealing piston upwards and thereby move the indicating piston upwards releasing said at least one relief hole through which the gaseous fluid can escape and thus return to the required pressure in
  • Figure 1 is a front view of the pressure regulator for verifying balloon inflation of endotracheal cannulas or tubes constructed in accordance with a preferred embodiment of the present invention.
  • Figure 2 is a bottom plan view of the pressure regulator of Figure 1.
  • Figure 3 is a first sectional view along line A-A ’of Figure 1.
  • Figure 4 is a perspective view along the line A-A 'of Figure 1.
  • a pressure regulator 10 is shown therein to verify the inflation of balloons of the endotracheal cannulas or tubes, in the present invention the term cannula or tube refers to the same object whereby its use is indistinct in the present description
  • the pressure regulator 10 comprises: a housing 20 that includes an inlet 21 to feed a gaseous fluid and an outlet 22 where a cannula or endotracheal tube connector that includes the balloon is coupled (not shown).
  • the housing 20 is divided into a flow chamber 40 and a pressure regulating chamber 60.
  • the regulator 10 includes a unidirectional valve 23 mounted at the inlet 21 to allow only the entry of the gaseous fluid into the flow chamber 40 and prevent leakage. or the return of the gaseous fluid that decrease the pressure in the balloon.
  • a separation wall 25 is included to divide the housing into two by separating the flow chamber 40 from the pressure regulating chamber 60.
  • the outlet 22 is in flow communication with both the flow chamber 40 and the pressure regulation chamber 60.
  • the housing 20 there are also a plurality of baffles 50 mounted in the flow chamber 40 to reduce the velocity of the gaseous fluid within the flow chamber 40, the plurality of baffles 50 defines a flow path between the inlet 21 and the outlet 22
  • a pressure indicating piston 70 movably mounted in the pressure regulating chamber 60 and which is visible by the user; within said regulating chamber 60 a sealing piston 80 is also provided in operative connection with the indicating piston 70 and below it in such a way that both move simultaneously.
  • the pistons 70 and 80 are connected to each other by a post 71.
  • the pressure regulating chamber 60 has a transparent upper wall 63 where the indicating piston 70 is visible in the event that it moves upwards, in this way the indicating piston and the upper wall allow to know if the balloon is at the pressure required
  • Said upper wall 63 has a curved wall shape with its upper end flattened, although it can take any form to be visible by the user.
  • the device 10 also comprises at least one pressure relief orifice 30 provided in the pressure regulating chamber, said orifice 30 being blocked by the sealing piston when the pressure in the balloon is less than a predetermined value.
  • tension means 90 comprising a base 91 mounted to the housing 20 and a flexible element 92 that connects the base 91 with the sealing piston 80 such that said flexible element 92 is initially tensioned for keeping the sealing piston 80 in a locked position when the pressure in the balloon of the endotracheal cannula is less than a predetermined pressure value and that in case there is a higher pressure in the balloon, the tension in the flexible element 92 is expired to allow upward movement of the sealing piston 80 and thereby the indicating piston 70 upwards releasing said relief hole 30.
  • the baffles 50 comprise vertical baffles and horizontal baffles such that a horizontal baffle is followed by a vertical baffle; of them, the horizontally positioned baffles partially cover the cross section of the flow chamber 40.
  • the flow chamber 40 has a front wall 41 and a rear wall 42, such that each of the horizontal baffles is internally separated from the front wall 41 and the rear wall 42 so that the gaseous fluid flows smoothly through the separation between the deflector and said front or rear wall.
  • the pressure regulating chamber 60 also has a front wall 61 and a rear wall 62, each wall including at least one relief hole 30, with respect to said relief holes 30 a group of three holes 30 is provided both on the front wall 61 and on the rear wall 62 of the pressure regulating chamber. Where the holes 30 of each group are distributed horizontally and equidistant from each other.

Abstract

The invention describes a pressure regulator for verifying the inflation of balloons of endotracheal cannulas or tubes, the regulator comprising: a cavity with an inlet and an outlet in which an endotracheal cannula or tube connector that includes the balloon is coupled. The cavity has a flow chamber and a pressure-regulating chamber; a one-way valve mounted on the inlet; the cavity also comprises a plurality of deflectors mounted in the flow chamber to reduce the velocity of the gaseous fluid. The regulator has a pressure-indicating piston mounted in a movable manner in the pressure-regulating chamber, which is visible to the user; a sealing piston operationally connected with the indicating piston and underneath same so that they both move simultaneously.

Description

“REGULADOR DE PRESIÓN PARA VERIFICAR  “PRESSURE REGULATOR TO VERIFY
EL INFLADO DE GLOBOS DE CÁNULAS O TUBOS ENDOTRAQUEALES”  THE INFLATION OF CANNULA BALLOONS OR ENDOTRACHAL TUBES ”
CAMPO DE LA INVENCIÓN FIELD OF THE INVENTION
La presente invención está relacionada con las técnicas empleadas en el diseño y construcción de aparatos y dispositivos para uso médico y, más particularmente, está relacionada con un regulador de presión para globos de cánulas o tubos endotraqueales que, permite evitar de manera automática tener una presión mayor a una presión establecida en el globo para la correcta intubación de un paciente.  The present invention is related to the techniques employed in the design and construction of apparatus and devices for medical use and, more particularly, it is related to a pressure regulator for cannula balloons or endotracheal tubes which, automatically prevents having a pressure greater than a pressure established in the balloon for the correct intubation of a patient.
ANTECEDENTES DE LA INVENCIÓN BACKGROUND OF THE INVENTION
Las cánulas o tubos endotraqueales son comúnmente utilizadas en el manejo de las vías respiratorias, particularmente, durante la anestesia general, cuidados críticos, ventilación mecánica y/o medicina de urgencias. Entre los componentes principales de las cánulas o tubos endotraqueales se encuentran un conector que es una pieza intermedia entre la cánula o el tubo y algún respirador o fuente de gases dirigidos al paciente; el conector normalmente se trata de una pieza mecánica estándar con una conexión tipo Luer bien conocida por los expertos en la técnica.  Endotracheal cannulas or tubes are commonly used in airway management, particularly during general anesthesia, critical care, mechanical ventilation and / or emergency medicine. Among the main components of the cannulae or endotracheal tubes are a connector that is an intermediate piece between the cannula or the tube and some respirator or gas source directed at the patient; The connector is usually a standard mechanical part with a Luer type connection well known to those skilled in the art.
La parte principal de las cánulas o tubos es en sí el cuerpo, conducto o tubo alargado que lleva el flujo de gas desde la fuente que provee los gases hasta el paciente. El tubo presenta normalmente una sección transversal circular.  The main part of the cannulas or tubes is itself the elongated body, duct or tube that carries the flow of gas from the source that supplies the gases to the patient. The tube normally has a circular cross section.
Ahora bien, cerca del extremo distal del cuerpo y envolviendo al mismo exteriormente se provee una parte que se infla conocida como globo, balón o pneumo que al inflarse ejerce presión sobre la mucosa traqueal para el correcto posicionamiento de la cánula o tubo dentro del paciente. En este particular, la presión dentro del globo debe mantenerse en ciertos valores como por ejemplo 25 cm de H20. Para inflar y regular la presión del globo, se utilizan válvulas de accionamiento manual, en este particular, es importante mencionar que la presión en el globo debe ser mantenida en valores óptimos para evitar daños al paciente. However, near the distal end of the body and externally wrapping there is provided an inflatable part known as a balloon, balloon or pneumo which, when inflated, puts pressure on the tracheal mucosa for the correct positioning of the cannula or tube inside the patient. In this particular, the pressure inside the balloon must be maintained at certain values such as 25 cm of H 2 0. To inflate and regulate the pressure of the balloon, manually operated valves are used, in this particular, it is important to mention that the pressure in the balloon it must be maintained at optimal values to avoid damage to the patient.
De lo anterior, se puede apreciar claramente que, durante la intubación, el personal médico ejecuta dos tareas, una de ellas es colocar cuidadosamente la cánula o el tubo dentro del paciente y la otra es inflar y regular la presión en el globo lo cual puede consumir tiempo y desviar la atención del personal médico de otras cosas importantes como lo es el mismo procedimiento anestésico. BREVE DESCRIPCIÓN DE LA INVENCIÓN From the above, it can be clearly seen that, during intubation, medical personnel perform two tasks, one of them is to carefully place the cannula or tube inside the patient and the other is to inflate and regulate the pressure on the balloon which can Consume time and divert the attention of medical staff from other important things such as the anesthetic procedure itself. BRIEF DESCRIPTION OF THE INVENTION
Con el objeto de superar los problemas del arte previo, se ha desarrollado un regulador de presión para verificar el inflado de globos de las cánulas o tubos endotraqueales, el regulador comprende como elementos principales: un alojamiento que incluye una entrada para alimentar un fluido gaseoso y una salida donde se acopla un conector de la cánula o tubo endotraqueal que incluye un globo alrededor de una porción de su extremo distal. El alojamiento se encuentra dividido en una cámara de flujo y una cámara de regulación de presión.  In order to overcome the problems of the prior art, a pressure regulator has been developed to verify the inflation of balloons of the cannulas or endotracheal tubes, the regulator comprises as main elements: a housing that includes an inlet to feed a gaseous fluid and an outlet where a cannula or endotracheal tube connector is attached that includes a balloon around a portion of its distal end. The housing is divided into a flow chamber and a pressure regulation chamber.
En la presente invención, existe una válvula unidireccional montada en la entrada para permitir sólo el ingreso del fluido gaseoso a la cámara de flujo y evitar fugas o el retorno del fluido gaseoso que disminuya la presión requerida en el globo.  In the present invention, there is a unidirectional valve mounted at the inlet to allow only the entry of the gaseous fluid into the flow chamber and avoid leaks or the return of the gaseous fluid that decreases the required pressure in the balloon.
En el regulador de presión, se provee una pluralidad de deflectores montados en la cámara de flujo para reducir la velocidad del fluido gaseoso dentro de dicha cámara, en este sentido, la pluralidad de deflectores define una trayectoria de flujo entre la entrada y la salida, en donde ésta última se encuentra en comunicación de flujo tanto con la cámara de flujo cómo con la cámara de regulación de presión.  In the pressure regulator, a plurality of baffles mounted in the flow chamber is provided to reduce the velocity of the gaseous fluid within said chamber, in this sense, the plurality of baffles defines a flow path between the inlet and the outlet, where the latter is in flow communication with both the flow chamber and the pressure regulating chamber.
En una modalidad preferida, la pluralidad de deflectores comprende deflectores verticales y deflectores horizontales de modo tal que un deflector horizontal es seguido de un deflector vertical. Se prefiere aún más que los deflectores colocados de forma horizontal cubran parcialmente la sección transversal de la cámara de flujo. Por su parte, la cámara de flujo tiene una pared frontal y una pared posterior, de modo que cada uno de los deflectores horizontales está separado internamente tanto de la pared frontal, así como de la pared posterior para que el fluido gaseoso fluya por la separación entre el deflector y dicha pared frontal o posterior.  In a preferred embodiment, the plurality of baffles comprises vertical baffles and horizontal baffles such that a horizontal baffle is followed by a vertical baffle. It is even more preferred that the horizontally positioned baffles partially cover the cross section of the flow chamber. For its part, the flow chamber has a front wall and a rear wall, so that each of the horizontal baffles is internally separated from both the front wall and the back wall so that the gaseous fluid flows through the separation between the deflector and said front or rear wall.
Ahora bien, en la presente invención es importante que el personal médico sepa y note si un valor de presión establecido ha sido sobrepasado, para ello se provee un pistón indicador de presión montado de forma desplazable en la cámara de regulación de presión y que es visible por el usuario, asimismo, se provee un pistón obturador operativamente conectado con el pistón indicador y por abajo del mismo de tal forma que ambos se pueden desplazar simultáneamente.  However, in the present invention it is important that medical personnel know and notice if an established pressure value has been exceeded, for this purpose a pressure indicating piston is mounted movably mounted in the pressure regulating chamber and is visible by the user, likewise, a sealing piston is operatively connected with the indicating piston and below it in such a way that both can move simultaneously.
En el alojamiento, se provee una pared para separar la cámara de flujo de la cámara de regulación de presión. La cámara de regulación de presión tiene una pared superior preferiblemente transparente por donde es visible el pistón indicador en caso de que éste se desplace hacia arriba al sobrepasar el valor de presión preestablecido en el globo, desde otro punto de vista, la pared transparente permite saber si el globo se encuentra inflado a la presión correcta. Para aliviar la presión en caso de que exista una sobrepresión en el globo, se provee al menos de un orificio de alivio localizado en la cámara de regulación de presión, dicho orificio comunica el interior del alojamiento con el exterior ambiental, y dicho orificio se encuentra bloqueado por el pistón obturador cuando la presión en el globo es menor al valor preestablecido. Asimismo, también se prefiere que la cámara de regulación tenga una pared frontal y una pared posterior, cada pared incluyendo al menos un orificio de alivio. Mas particularmente, se prefiere proveer un grupo de tres orificios tanto en la pared frontal y otro grupo en la pared posterior, en donde los orificios de cada grupo están distribuidos de forma horizontal y equidistantemente entre sí. In the housing, a wall is provided to separate the flow chamber from the pressure regulating chamber. The pressure regulating chamber has a preferably transparent upper wall where the indicating piston is visible in case it moves upwards when the preset pressure value in the balloon exceeds, from another point of view, the transparent wall allows to know if the balloon is inflated to the correct pressure. To relieve the pressure in case there is an overpressure in the balloon, at least one relief orifice is provided located in the pressure regulating chamber, said orifice communicates the interior of the housing with the environmental exterior, and said orifice is located blocked by the sealing piston when the pressure in the balloon is less than the preset value. Likewise, it is also preferred that the regulating chamber has a front wall and a rear wall, each wall including at least one relief hole. More particularly, it is preferred to provide a group of three holes both in the front wall and another group in the rear wall, where the holes in each group are distributed horizontally and equidistant from each other.
La presente invención también incluye medios de tensión que comprende una base o ancla montada al alojamiento y un elemento flexible que conecta la base con el pistón obturador de tal modo que el elemento flexible se encuentra tenso para mantener el pistón obturador en una posición de bloqueo cuando la presión en el globo es menor a dicho valor predeterminado y que en caso de que exista una presión mayor en el globo, la tensión en el elemento flexible es vencida para desplazar en forma ascendente el pistón obturador y con ello mover el pistón indicador hacia arriba liberando dicho al menos un orificio de alivio por donde puede escapar el fluido gaseoso y así volver a la presión requerida en el globo.  The present invention also includes tension means comprising a base or anchor mounted to the housing and a flexible element that connects the base with the sealing piston such that the flexible element is tense to keep the sealing piston in a locked position when the pressure in the balloon is lower than said predetermined value and in case there is a higher pressure in the balloon, the tension in the flexible element is overcome to move the sealing piston upwards and thereby move the indicating piston upwards releasing said at least one relief hole through which the gaseous fluid can escape and thus return to the required pressure in the balloon.
BREVE DESCRIPCIÓN DE LAS FIGURAS DE LA INVENCIÓN BRIEF DESCRIPTION OF THE FIGURES OF THE INVENTION
Los aspectos novedosos que se consideran característicos de la presente invención se establecerán con particularidad en las reivindicaciones anexas. Sin embargo, la invención misma conjuntamente con otros objetos y ventajas de ella, se comprenderá mejor en la siguiente descripción detallada de ciertas modalidades preferidas de la invención, cuando se lea en relación con los dibujos que se acompañan, en los cuales:  The novel aspects that are considered characteristic of the present invention will be established with particularity in the appended claims. However, the invention itself, together with other objects and advantages thereof, will be better understood in the following detailed description of certain preferred embodiments of the invention, when read in relation to the accompanying drawings, in which:
La figura 1 es una vista frontal del regulador de presión para verificar el inflado de globos de las cánulas o tubos endotraqueales construido de conformidad con una modalidad preferida de la presente invención.  Figure 1 is a front view of the pressure regulator for verifying balloon inflation of endotracheal cannulas or tubes constructed in accordance with a preferred embodiment of the present invention.
La figura 2 es una vista en planta inferior del regulador de presión de la figura 1 . Figure 2 is a bottom plan view of the pressure regulator of Figure 1.
La figura 3 es una primera vista en corte a lo largo de la línea A-A’ de la figura 1 .Figure 3 is a first sectional view along line A-A ’of Figure 1.
La figura 4 es una vista en perspectiva a lo largo de la línea A-A’ de la figura 1 . BREVE DESCRIPCIÓN DE Figure 4 is a perspective view along the line A-A 'of Figure 1. BRIEF DESCRIPTION OF
LAS MODALIDADES PREFERIDAS DE LA INVENCIÓN  THE PREFERRED MODES OF THE INVENTION
Haciendo referencia a las figuras 1 a 4 de los dibujos anexos, en ellas se muestra, un regulador de presión 10 para verificar el inflado de globos de las cánulas o tubos endotraqueales, en la presente invención el término cánula o tubo se refiere al mismo objeto por lo que su uso es indistinto en la presente descripción, el regulador de presión 10 comprende: un alojamiento 20 que incluye una entrada 21 para alimentar un fluido gaseoso y una salida 22 donde se acopla un conector de cánula o tubo endotraqueal que incluye el globo (no mostrado). El alojamiento 20 está dividido en una cámara de flujo 40 y una cámara de regulación de presión 60. El regulador 10 incluye una válvula unidireccional 23 montada en la entrada 21 para permitir sólo el ingreso del fluido gaseoso a la cámara de flujo 40 y evitar fugas o el retorno del fluido gaseoso que disminuyan la presión en el globo.  Referring to Figures 1 to 4 of the accompanying drawings, a pressure regulator 10 is shown therein to verify the inflation of balloons of the endotracheal cannulas or tubes, in the present invention the term cannula or tube refers to the same object whereby its use is indistinct in the present description, the pressure regulator 10 comprises: a housing 20 that includes an inlet 21 to feed a gaseous fluid and an outlet 22 where a cannula or endotracheal tube connector that includes the balloon is coupled (not shown). The housing 20 is divided into a flow chamber 40 and a pressure regulating chamber 60. The regulator 10 includes a unidirectional valve 23 mounted at the inlet 21 to allow only the entry of the gaseous fluid into the flow chamber 40 and prevent leakage. or the return of the gaseous fluid that decrease the pressure in the balloon.
Dentro del alojamiento 20 se incluye una pared de separación 25 para dividir el alojamiento en dos separando la cámara de flujo 40 de la cámara de regulación de presión 60. La salida 22 se encuentra en comunicación de flujo tanto con la cámara de flujo 40 y la cámara de regulación de presión 60.  Inside the housing 20 a separation wall 25 is included to divide the housing into two by separating the flow chamber 40 from the pressure regulating chamber 60. The outlet 22 is in flow communication with both the flow chamber 40 and the pressure regulation chamber 60.
Dentro del alojamiento 20 también existen una pluralidad de deflectores 50 montados en la cámara de flujo 40 para reducir la velocidad del fluido gaseoso dentro de la cámara de flujo 40, la pluralidad de deflectores 50 define una trayectoria de flujo entre la entrada 21 y la salida 22.  Within the housing 20 there are also a plurality of baffles 50 mounted in the flow chamber 40 to reduce the velocity of the gaseous fluid within the flow chamber 40, the plurality of baffles 50 defines a flow path between the inlet 21 and the outlet 22
Dentro de la cámara de regulación de presión 60, existe un pistón indicador 70 de presión montado de forma desplazable en la cámara de regulación de presión 60 y que es visible por el usuario; dentro de dicha cámara de regulación 60 también se provee un pistón obturador 80 en conexión operativa con el pistón indicador 70 y por abajo del mismo de tal forma que ambos se desplazan simultáneamente. Para ello, los pistones 70 y 80 se encuentran conectados entre sí mediante un poste 71 .  Within the pressure regulating chamber 60, there is a pressure indicating piston 70 movably mounted in the pressure regulating chamber 60 and which is visible by the user; within said regulating chamber 60 a sealing piston 80 is also provided in operative connection with the indicating piston 70 and below it in such a way that both move simultaneously. For this, the pistons 70 and 80 are connected to each other by a post 71.
La cámara de regulación de presión 60 tiene una pared superior 63 transparente por donde es visible el pistón indicador 70 en caso de que este se desplace hacia arriba, de este modo el pistón indicador y la pared superior permiten saber si el globo se encuentra a la presión requerida. Dicha pared superior 63 tiene forma de pared curva con su extremo superior achatado, aunque puede tomar cualquier forma para ser visible por el usuario.  The pressure regulating chamber 60 has a transparent upper wall 63 where the indicating piston 70 is visible in the event that it moves upwards, in this way the indicating piston and the upper wall allow to know if the balloon is at the pressure required Said upper wall 63 has a curved wall shape with its upper end flattened, although it can take any form to be visible by the user.
Ahora bien, el dispositivo 10 también comprende al menos un orificio 30 de alivio de presión provisto en la cámara de regulación de presión, dicho orificio 30 estando bloqueado por el pistón obturador cuando la presión en el globo es menor a un valor predeterminado. Un punto importante es que la presente invención comprende medios de tensión 90 que comprende una base 91 montada al alojamiento 20 y un elemento flexible 92 que conecta la base 91 con el pistón obturador 80 de tal modo que dicho elemento flexible 92 se encuentra inicialmente tenso para mantener el pistón obturador 80 en una posición de bloqueo cuando la presión en el globo de la cánula endotraqueal es menor a un valor de presión predeterminado y que en caso de que exista una presión mayor en el globo, la tensión en el elemento flexible 92 es vencida para permitir desplazar en forma ascendente el pistón obturador 80 y con ello el pistón indicador 70 hacia arriba liberando dicho orificio de alivio 30. However, the device 10 also comprises at least one pressure relief orifice 30 provided in the pressure regulating chamber, said orifice 30 being blocked by the sealing piston when the pressure in the balloon is less than a predetermined value. An important point is that the present invention comprises tension means 90 comprising a base 91 mounted to the housing 20 and a flexible element 92 that connects the base 91 with the sealing piston 80 such that said flexible element 92 is initially tensioned for keeping the sealing piston 80 in a locked position when the pressure in the balloon of the endotracheal cannula is less than a predetermined pressure value and that in case there is a higher pressure in the balloon, the tension in the flexible element 92 is expired to allow upward movement of the sealing piston 80 and thereby the indicating piston 70 upwards releasing said relief hole 30.
Describiendo un poco más en detalle a la cámara de flujo40, los deflectores 50 comprenden deflectores verticales y deflectores horizontales de modo tal que un deflector horizontal es seguido de un deflector vertical; de ellos, los deflectores colocados de forma horizontal cubren parcialmente la sección transversal de la cámara de flujo 40.  Describing the flow chamber 40 in more detail, the baffles 50 comprise vertical baffles and horizontal baffles such that a horizontal baffle is followed by a vertical baffle; of them, the horizontally positioned baffles partially cover the cross section of the flow chamber 40.
La cámara de flujo 40 tiene una pared frontal 41 y una pared posterior 42, de modo tal que cada uno de los deflectores horizontales está separado internamente de la pared frontal 41 y la pared posterior 42 para que el fluido gaseoso fluya suavemente por la separación entre el deflector y dicha pared frontal o posterior.  The flow chamber 40 has a front wall 41 and a rear wall 42, such that each of the horizontal baffles is internally separated from the front wall 41 and the rear wall 42 so that the gaseous fluid flows smoothly through the separation between the deflector and said front or rear wall.
Por su parte, la cámara de regulación de presión 60 también cuenta con una pared frontal 61 y una pared posterior 62, cada pared incluyendo al menos un orificio de alivio 30, respecto a dichos orificios de alivio 30 se provee un grupo de tres orificios 30 tanto en la pared frontal 61 como en la pared posterior 62 de la cámara de regulación de presión. En donde los orificios 30 de cada grupo están distribuidos de forma horizontal y equidistante entre sí.  For its part, the pressure regulating chamber 60 also has a front wall 61 and a rear wall 62, each wall including at least one relief hole 30, with respect to said relief holes 30 a group of three holes 30 is provided both on the front wall 61 and on the rear wall 62 of the pressure regulating chamber. Where the holes 30 of each group are distributed horizontally and equidistant from each other.
De acuerdo con lo anteriormente descrito, será evidente para un técnico en la materia que la modalidad de regulador de presión antes descrito se presenta con fines únicamente ilustrativos, pues un técnico en la materia puede realizar numerosas variaciones a la misma, siempre y cuando se diseñen de conformidad con los principios de la presente invención. Por consecuencia de lo anterior, la presente invención incluye todas las modalidades que un técnico en la materia puede plantear a partir de los conceptos contenidos en la presente descripción, de conformidad con las siguientes reivindicaciones. LISTA DE REFERENCIAS In accordance with the above, it will be apparent to a person skilled in the art that the pressure regulator modality described above is presented for illustrative purposes only, since a person skilled in the art can make numerous variations thereto, provided they are designed in accordance with the principles of the present invention. As a consequence of the foregoing, the present invention includes all the modalities that a person skilled in the art can raise from the concepts contained in the present description, in accordance with the following claims. REFERENCE LIST
10 Regulador de presión 10 Pressure regulator
20 Alojamiento 20 Accommodation
21 Entrada  21 Entry
22 Salida  22 Departure
23 Válvula  23 Valve
25 Pared de Separación  25 Separation Wall
30 Orificios de alivio 30 relief holes
40 Cámara de Flujo 40 Flow Chamber
41 Pared frontal  41 Front wall
42Pared Posterior  42 Back Wall
50 Deflectores 50 Deflectors
60 Cámara de Regulación de Presión 60 Pressure Regulation Chamber
61 Pared Frontal  61 Front Wall
62Pared posterior  62 Back wall
63 Pared superior  63 Top Wall
70 Pistón Indicador 70 Piston Indicator
71 Poste  71 Post
80 Pistón Obturador 80 Shutter Piston
90 Medios de Tensión 90 Tension Means
91 Base  91 Base
92 Elemento elástico  92 Elastic Element

Claims

REIVINDICACIONES
1 Un regulador de presión para verificar el inflado de los globos de cánulas o tubos endotraqueales, caracterizado porque comprende:  1 A pressure regulator to verify inflation of cannula balloons or endotracheal tubes, characterized in that it comprises:
un alojamiento que incluye una entrada para alimentar un fluido gaseoso y una salida donde se acopla un conector de cánula o tubo endotraqueal que incluye el globo, el alojamiento estando dividido en una cámara de flujo y una cámara de regulación de presión; una válvula unidireccional montada en la entrada para permitir sólo el ingreso del fluido gaseoso a la cámara de flujo y evitar fugas o el retorno del fluido gaseoso que disminuyan la presión en el globo;  a housing that includes an inlet to feed a gaseous fluid and an outlet where a cannula or endotracheal tube connector is included that includes the balloon, the housing being divided into a flow chamber and a pressure regulating chamber; a unidirectional valve mounted at the inlet to allow only the entry of the gaseous fluid into the flow chamber and avoid leaks or the return of the gaseous fluid that lower the pressure in the balloon;
una pluralidad de deflectores montados en la cámara de flujo para reducir la velocidad del fluido gaseoso dentro de la cámara de flujo, la pluralidad de deflectores definiendo una trayectoria de flujo entre la entrada y la salida;  a plurality of baffles mounted in the flow chamber to reduce the velocity of the gaseous fluid within the flow chamber, the plurality of baffles defining a flow path between the inlet and the outlet;
un pistón indicador de presión montado de forma desplazable en la cámara de regulación de presión y que es visible por el usuario;  a pressure indicating piston movably mounted in the pressure regulating chamber and which is visible by the user;
un pistón obturador en conexión operativa con el pistón indicador y por abajo del mismo de tal forma que ambos se desplazan simultáneamente;  a sealing piston in operative connection with the indicating piston and below it in such a way that both move simultaneously;
al menos un orificio de alivio de presión provisto en la cámara de regulación de presión, dicho orificio estando bloqueado por el pistón obturador cuando la presión en el globo es menor a un valor predeterminado;  at least one pressure relief orifice provided in the pressure regulating chamber, said orifice being blocked by the sealing piston when the pressure in the balloon is less than a predetermined value;
medios de tensión que comprenden una base montada al alojamiento y un elemento flexible que conecta la base con el pistón obturador de tal modo que dichos medios mantienen el pistón obturador en una posición de bloqueo cuando la presión en el globo de la cánula o tubo endotraqueales menor a dicho valor predeterminado y que en caso de que exista una presión mayor en el globo, la tensión en el elemento flexible es vencida para desplazar en forma ascendente el pistón obturador y con ello el pistón indicador se desplaza hacia arriba liberando dicho orificio de alivio.  tension means comprising a base mounted to the housing and a flexible element that connects the base with the sealing piston such that said means keep the sealing piston in a locked position when the pressure in the balloon of the cannula or endotracheal tube is lower at said predetermined value and in case there is a greater pressure in the balloon, the tension in the flexible element is overcome to move the sealing piston upwards and with it the indicating piston moves upwards releasing said relief hole.
2. Un regulador de presión de conformidad con la reivindicación 1 , caracterizado porque la pluralidad de deflectores comprende deflectores verticales y deflectores horizontales de modo tal que un deflector horizontal es seguido de un deflector vertical. 2. A pressure regulator according to claim 1, characterized in that the plurality of deflectors comprises vertical deflectors and horizontal deflectors such that a horizontal deflector is followed by a vertical deflector.
3. Un regulador de presión de conformidad con la reivindicación 2, caracterizado porque los deflectores colocados de forma horizontal cubren parcialmente la sección transversal de la cámara de flujo. 3. A pressure regulator according to claim 2, characterized in that the horizontally positioned baffles partially cover the cross section of the flow chamber.
4. Un regulador de presión de conformidad con la reivindicación 3, caracterizado porque la cámara de flujo tiene una pared frontal y una pared posterior, de modo que cada uno de los deflectores horizontales está separado internamente de la pared frontal y la pared posterior para que el fluido gaseoso fluya por la separación entre el deflector y dicha pared frontal o posterior. 4. A pressure regulator according to claim 3, characterized in that the flow chamber has a front wall and a rear wall, so that each of the horizontal baffles is internally separated from the front wall and the rear wall so that the gaseous fluid flows through the separation between the deflector and said front or rear wall.
5. Un regulador de presión de conformidad con la reivindicación 1 , caracterizado porque la cámara de regulación tiene una pared frontal y una pared posterior, cada pared incluyendo al menos un orificio de alivio. 5. A pressure regulator according to claim 1, characterized in that the regulating chamber has a front wall and a rear wall, each wall including at least one relief hole.
6. Un regulador de presión de conformidad con la reivindicación 5, caracterizado porque se provee un grupo de tres orificios tanto en la pared frontal y la pared posterior, en donde los orificios de cada grupo están distribuidos de forma horizontal y equidistantes entre sí. A pressure regulator according to claim 5, characterized in that a group of three holes is provided both in the front wall and the rear wall, wherein the holes of each group are distributed horizontally and equidistant from each other.
7. Un regulador de presión de conformidad con la reivindicación 1 , caracterizado porque el alojamiento incluye una pared de separación para separar la cámara de flujo de la cámara de regulación de presión. 7. A pressure regulator according to claim 1, characterized in that the housing includes a separation wall for separating the flow chamber from the pressure regulating chamber.
8. Un regulador de presión de conformidad con la reivindicación 1 , caracterizado porque se provee un poste para conectar el pistón indicador con el pistón obturador. 8. A pressure regulator according to claim 1, characterized in that a post is provided for connecting the indicating piston with the sealing piston.
9. Un regulador de presión de conformidad con la reivindicación 1 , caracterizado porque la salida se encuentra en comunicación de flujo tanto con la cámara de flujo y la cámara de regulación de presión. 9. A pressure regulator according to claim 1, characterized in that the output is in flow communication with both the flow chamber and the pressure regulating chamber.
10. Un regulador de presión de conformidad con la reivindicación 1 , caracterizado porque la cámara de regulación de presión tiene una pared superior transparente por donde es visible el pistón indicador en caso de que éste se desplace hacia arriba. 10. A pressure regulator according to claim 1, characterized in that the pressure regulating chamber has a transparent upper wall where the indicating piston is visible in the event that it moves upwards.
1 1 . Un regulador de presión de conformidad con la reivindicación 10 caracterizado porque la pared superior tiene forma curva con su extremo superior achatado para ser visible por el usuario. eleven . A pressure regulator according to claim 10 characterized in that the upper wall is curved in shape with its upper end flattened to be visible by the user.
PCT/IB2018/052059 2018-03-26 2018-03-26 Pressure regulator for verifying the inflation of balloons of endotracheal cannulas or tubes WO2019186230A1 (en)

Priority Applications (4)

Application Number Priority Date Filing Date Title
PCT/IB2018/052059 WO2019186230A1 (en) 2018-03-26 2018-03-26 Pressure regulator for verifying the inflation of balloons of endotracheal cannulas or tubes
US17/040,847 US20220105321A1 (en) 2018-03-26 2018-03-26 Pressure regulator for verifying the inflation of balloons of endotracheal cannulas or tubes
MX2020009932A MX2020009932A (en) 2018-03-26 2018-03-26 Pressure regulator for verifying the inflation of balloons of endotracheal cannulas or tubes.
CONC2020/0013109A CO2020013109A2 (en) 2018-03-26 2020-10-20 Pressure regulator to verify balloon inflation of endotracheal tubes or tubes

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Application Number Priority Date Filing Date Title
PCT/IB2018/052059 WO2019186230A1 (en) 2018-03-26 2018-03-26 Pressure regulator for verifying the inflation of balloons of endotracheal cannulas or tubes

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CO (1) CO2020013109A2 (en)
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Citations (6)

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Publication number Priority date Publication date Assignee Title
US3985141A (en) * 1975-03-10 1976-10-12 The University Of Utah Inflation and pressure relief valve
US4159722A (en) * 1977-03-28 1979-07-03 Sherwood Medical Industries, Inc. Pressure regulator for endotracheal tube cuff or the like
US4617015A (en) * 1984-08-10 1986-10-14 Halkey-Roberts Corporation Visual pressure indicator for endotracheal cuff
DE3640378A1 (en) * 1986-11-26 1988-06-01 Schnell Reinhard C F Angioplasty device
US4770170A (en) * 1985-07-03 1988-09-13 Tottori University Cuff pressure regulator for endotracheal-tube cuff
EP2060293A1 (en) * 2007-11-14 2009-05-20 Advanex Inc. Indicator for cuffed medical device

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Publication number Priority date Publication date Assignee Title
US4501273A (en) * 1982-09-30 1985-02-26 Mcginnis Gerald E Endotracheal tube with pressure controlled inflatable cuff
US4526196A (en) * 1983-01-26 1985-07-02 Nayan S. Shah Gas pressure measuring and regulating device and method
US11247011B2 (en) * 2017-12-26 2022-02-15 Xialing Zhang Pressure controller and tracheal breathing tube comprising same

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3985141A (en) * 1975-03-10 1976-10-12 The University Of Utah Inflation and pressure relief valve
US4159722A (en) * 1977-03-28 1979-07-03 Sherwood Medical Industries, Inc. Pressure regulator for endotracheal tube cuff or the like
US4617015A (en) * 1984-08-10 1986-10-14 Halkey-Roberts Corporation Visual pressure indicator for endotracheal cuff
US4770170A (en) * 1985-07-03 1988-09-13 Tottori University Cuff pressure regulator for endotracheal-tube cuff
DE3640378A1 (en) * 1986-11-26 1988-06-01 Schnell Reinhard C F Angioplasty device
EP2060293A1 (en) * 2007-11-14 2009-05-20 Advanex Inc. Indicator for cuffed medical device

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US20220105321A1 (en) 2022-04-07
MX2020009932A (en) 2020-10-14

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